The safety and efficacy of indwelling intraperitoneal (IP) catheters for the management of refractory malignant ascites is unclear. A systematic literature overview and retrospective chart review of patients with malignant refractory ascites who underwent indwelling IP catheter placement was performed. Standardized literature abstraction and chart review templates were used to ensure that consistent information was collected. Fifteen publications met literature search criteria, representing 221 patients. Tenckhoff (Quinton Instrument Company, Seattle, WA, USA), Pleurex (Denver Biomedical Inc., Golden, CO, USA), and peritoneal catheters were used, along with IP ports. A median 5.9% of cases (range: 2.5%-34%) had documented peritonitis. In the literature, untunneled catheters were most commonly associated with infections. Our chart review added 19 cases from two academic institutions to this literature (median age: 60 years [range: 31-85]; females: 17 [89%]; gynecological malignancies: 14 [73%]). Palliative management before catheter placement included diuretics (n=4 [21%]) and multiple paracenteses (n=11 [58%] had two or more taps [range: 2-8]). Median time from diagnosis to catheter placement was 25 months (range: 1-77). Interventions were: French pigtail catheters (n=16 [84%]), Tenckhoff catheter (n=1 [5%]), and Port-A-Caths (Smith Medical MD, St. Paul, MN, USA) (n=2; 11%). Four (21%) catheters were tunneled. Prophylactic antibiotics were prescribed in six cases (32%). Two cases (11%) had documented infections, seven catheters (37%) became occluded, and two leaked (11%). The median time from catheter until death was 36 days (range: 4-660). Nine patients (47%) were admitted to hospice. In these retrospective studies, indwelling IP catheters appear to be a safe and effective palliative strategy to manage refractory malignant ascites, without overwhelming infection rates.
The objective of this study was to evaluate the treatment outcomes and risk factors of women with surgical stage I endometrial adenocarcinoma who were initially treated with surgery alone and subsequently developed isolated vaginal recurrences. Patients with surgical stage I endometrial adenocarcinoma diagnosed from 1975 to 2002 were identified from tumor registry databases at seven institutions. All patients were treated with surgery alone including a total hysterectomy, bilateral salpingo-oophorectomy, pelvic (+/- para-aortic) lymph node dissection, and peritoneal cytology and did not receive postoperative radiation therapy. Vaginal recurrences were documented histologically. Metastatic disease in the chest and abdomen was excluded by radiologic studies. Overall survival was calculated by the Kaplan-Meier method. Sixty-nine women with surgical stage I endometrial cancer with isolated vaginal recurrences were identified. Of the 69 patients, 10 (15%) were diagnosed with stage IA disease, 43 (62%) were diagnosed with stage IB disease, and 16 (23%) were diagnosed with stage IC disease. Patients diagnosed with grade 1 disease were 22 (32%), grade 2 disease were 26 (38%), and grade 3 disease were 21 (30%). Among women, 81% with isolated vaginal recurrences were salvaged with radiation therapy. The mean time to recurrence was 24 months, and the mean follow-up was 63 months. Among women, 18% died from subsequent recurrent disease. The 5-year overall survival was 75%. The majority of isolated vaginal recurrences in women with surgical stage I endometrial cancer can be successfully salvaged with radiation therapy, further questioning the role of adjuvant therapy for patients with uterine-confined endometrial cancer at the time of initial diagnosis.
Purpose
Preclinical data suggests concurrent inhibition of VEGF, mTOR and
EGFR pathways may augment anti-tumor and anti-angiogenic effects compared to
inhibition of each pathway alone. This study evaluated the maximum tolerated
dose /recommended phase II dose and safety and tolerability of bevacizumab,
everolimus and panitumumab drug combination.
Methods
Subjects with advanced solid tumors received escalating doses of
everolimus and flat dosing of panitumumab at 4.8 mg/kg and bevacizumab at 10
mg/kg every two weeks. Dose limiting toxicities (DLTs) were assessed in
cycle 1; toxicity evaluation was closely monitored throughout treatment.
Treatment continued until disease progression or undesirable toxicity.
Results
Thirty-two subjects were evaluable for toxicity; 31 subjects were
evaluable for tumor response. DLTs were observed in cohorts with everolimus
at 10 and 5 mg daily and included grade 3 mucositis, skin rash and
thrombocytopenia. Therefore, everolimus was dose-reduced to 5 mg three times
weekly which improved tolerability of the treatment regimen. Common adverse
events were skin rash/pruritus (91%), mucositis/stomatitis (75%),
hypomagnesemia (72%), hypocalcemia (56%) and hypokalemia (50%). There were 3
partial responses; an additional 10 subjects had stable disease ≥6
months. Three subjects with ovarian cancer and one with endometrial cancer
achieved prolonged disease control ranging from 11 to >40 months.
Conclusions
The recommended phase II dose is everolimus at 5 mg three times
weekly plus panitumumab at 4.8 mg/kg and bevacizumab at 10 mg/kg every two
weeks. This dosing regimen has an acceptable safety and tolerability profile
and appears to have moderate clinical activity in refractory tumors.
Purpose
GOG 152 was a randomized trial of secondary cytoreductive surgery (SCS) in patients with suboptimal residual disease (residual tumor nodule >1 cm in greatest diameter) following primary cytoreductive surgery for advanced stage ovarian cancer. The current analysis was undertaken to evaluate the impact of disease findings at SCS on progression-free survival (PFS) and overall survival (OS).
Methods
Among the 550 patients enrolled on GOG-152, two-hundred-sixteen patients were randomly assigned following 3 cycles of cisplatin and paclitaxel to receive SCS. In 15 patients (7%) surgery was declined or contraindicated. In the remaining 201 patients the operative and pathology reports were utilized to classify their disease status at the beginning of SCS as; no gross disease/microscopically negative N= 40 (19.9%), no gross disease/microscopically positive N= 8 (4.0%), and gross disease N=153 (76.1%).
Results
The median PFS for patients with no gross disease/microscopically negative was 16.1 months, no gross disease/microscopically positive was 13.5 months and for gross disease was 11.7 months, p=0.002. The median OS for patients with no gross disease/microscopically negative was 51.5 months, no gross disease/microscopically positive was 42.6 months and for gross disease was 34.9 months, p=0.018.
Conclusion
Although as previously reported SCS did not change PFS or OS, for those who underwent the procedure, their operative and pathologic findings were predictive of PFS and OS. Surgical/pathological residual disease is a biomarker of response to chemotherapy and predictive of PFS and OS.
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